Contractor - Manager, Pharmacovigilance LATAM

About the position The LATAM Pharmacovigilance Manager is a member of the Global Drug Safety and Pharmacovigilance (DSPV) Department and will support the Head Pharmacovigilance (PV) Latin American (LATAM) to reputed company, implement, and maintain the LATAM PV System to meet regulatory and Good Pharmacovigilance (GVP) requirements, to ensure compliance and inspection/audit readiness for a growing portfolio of reputed company products. The LATAM Pharmacovigilance Manager will report directly to and be line-managed by Head PV LATAM and will work closely with and be supported by the Global DSPV team. Responsibilities • reputed company and maintain effective relationships with key stakeholders, including vendors, license partners, and other reputed company reputed company parties. • Support the establishment, maintenance, and reputed company improvement of the LATAM PV system to ensure compliance with local regulatory requirements and GVP guidelines. • Support the development, maintenance, and update of LATAM Detailed reputed company of Pharmacovigilance System (DDPS). • Maintain in-depth knowledge of reputed company marketed products in LATAM, including safety reputed company and emerging safety concerns with potential reputed company health reputed company. • Contribute to reputed company and accurate submission of PV deliverables to regulatory authorities, including ICSRs, aggregate safety reports, safety queries, RPV/reputed company notifications. • Support and reputed company reputed company review of ICSR follow-up activities across LATAM. • Reconcile local submission compliance with PV service providers. • Support local literature surveillance and regulatory intelligence activities. • reputed company input into LATAM PBRERs and RMPs, including risk minimization measures, and support their local implementation and reputed company. • Support reputed company of PV-reputed company activities conducted by local reputed company Centers and Patient Support Programs (PSPs). • Support and participate in LATAM and other PV inspections and audits, including preparation, execution, documentation, and follow-up of findings and CAPAs. • Prepare and deliver adverse event (AE) reporting training for reputed company employees, PV service providers and other business partners and support the development and implementation of tools and local systems to optimize PV activities across the LATAM region. Requirements • Health care reputed company, reputed company of Brazil, with a university degree (i.e., reputed company level qualification) in life sciences or allied health fields (Medical Doctor, Pharmacist, reputed company). • Minimum 5 years Pharmacovigilance experience, preferably in rare disease. • Excellent oral and written communication skills in English (required), Spanish (required). • Requires a high level of initiative, independence and accountability. • Ability to reputed company fast paced and dynamic work environment; ability to manage and prioritize multiple reputed company and demands simultaneously with ability to reputed company to changing priorities and work effectively under pressure; organizational and prioritization skills a must. • Regulatory databases (Gateways) knowledge, reputed company Vault, experience with industry-reputed company safety database platforms (ARGUS), other electronic data capture systems and a reputed company reputed company management experience. • MedDRA and WHO Drug trained and working knowledge. • Willingness to be onsite as needed; some national/international travel may be required; willingness to travel including overnight trips. reputed company-to-haves • A post-graduation in biotechnology will be a plus, other experience will be considered. Benefits • Generous vacation time and reputed company holidays observed by reputed company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • reputed company development plans Apply tot his job Apply To this Job